Back to resultsProof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)
Primary Purpose
Hepatitis D
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EBP921
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis D focused on measuring Hepatitis D, HDV, Hepatitis
Eligibility Criteria
Inclusion Criteria:
- Men and women age 18 or older with the capacity to give written informed consent
- Patients with compensated chronic HDV infection as indicated by presence of anti-HDV in serum.
- Liver biopsy should be performed within one-year of study screening and graded using the Knodell scoring system.
- Presence of HDV antigen in liver tissue or HDV-RNA in serum.
- Active HBV replication will not exclude patients.
- Previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
- Patients who are HBV therapy-naïve or who previously received HBV antiviral therapy will be eligible. Patients currently taking HBV antiviral therapy will e considered on a case basis.
- Female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of EBP921 dosing.
Exclusion Criteria:
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
- Pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
- Underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, HIV antibody positive, AIDS)
- Chronic (> 4 weeks duration) diarrhea
- Body weight > 128 kg and < 40 kg
- Uncompensated cirrhosis
- Absolute neutrophil count less than 1500 per cubic millimeter
- Platelet count less than 90,000 per cubic millimeter
- Evidence of concurrent HCV infection with positive serum HCVRNA
- Evidence of hepatocellular carcinoma
- Active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
- Diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
- Any experimental therapy in the previous 6 months prior to enrollment.
16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Low Dose for 28 days: n=4
High Dose for 28 days; n=4
Outcomes
Primary Outcome Measures
Change in HDV-RNA
The primary efficacy endpoint will be the median change in HDV-RNA from baseline to HDV RNA nadir as measured by quantitative PCR during the 28-day dosing period.
Secondary Outcome Measures
Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8
The median change in HDV RNA from baseline to Days 7, 14, 28, and post-therapy Weeks 1, 2, 4, and 8 of the study; the proportion of patients with alanine aminotransferase (ALT) normalization defined as ALT ≤ upper limit of normal for patients with ALT > ULN at baseline; assessment of peripheral blood mononuclear cell (PBMC) proliferation after 14 and 28 days exposure to EBP921; the percentage of patients with undetectable HDV RNA at Days 7, 14, 28, post-therapy Weeks 1, 2, 4, and 8; the median change in HBV DNA at Days 7, 14, 21, 28, 35, and 42, and HBsAg at Days 14, 28, and 42.
Full Information
NCT ID
NCT01316185
First Posted
March 14, 2011
Last Updated
August 4, 2016
Sponsor
Eiger BioPharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01316185
Brief Title
Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)
Official Title
An Open Label, Dose-ranging Proof-of-concept Study Assessing the Safety and Efficacy of EBP921 in Therapy-naive Patients Chronically Infected With Delta Hepatitis (HDV)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
the enrollment was slow and never completed.
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eiger BioPharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy and safety of 2 dose regimens in patients with chronic HDV.
Detailed Description
This is an open-label, phase 1b, proof-of-concept study to assess the safety and efficacy of EBP921, a prenylation inhibitor, in subjects chronically infected with delta hepatitis. Subjects will be randomized to receive one of two different doses of EBP921. Dosing will occur over 28-days and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA via PCR assay. In addition, safety lab data will also be collected along with surveillance monitoring of HBV activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis D
Keywords
Hepatitis D, HDV, Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Low Dose for 28 days: n=4
Arm Title
Group 2
Arm Type
Experimental
Arm Description
High Dose for 28 days; n=4
Intervention Type
Drug
Intervention Name(s)
EBP921
Intervention Description
Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.
Primary Outcome Measure Information:
Title
Change in HDV-RNA
Description
The primary efficacy endpoint will be the median change in HDV-RNA from baseline to HDV RNA nadir as measured by quantitative PCR during the 28-day dosing period.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8
Description
The median change in HDV RNA from baseline to Days 7, 14, 28, and post-therapy Weeks 1, 2, 4, and 8 of the study; the proportion of patients with alanine aminotransferase (ALT) normalization defined as ALT ≤ upper limit of normal for patients with ALT > ULN at baseline; assessment of peripheral blood mononuclear cell (PBMC) proliferation after 14 and 28 days exposure to EBP921; the percentage of patients with undetectable HDV RNA at Days 7, 14, 28, post-therapy Weeks 1, 2, 4, and 8; the median change in HBV DNA at Days 7, 14, 21, 28, 35, and 42, and HBsAg at Days 14, 28, and 42.
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women age 18 or older with the capacity to give written informed consent
Patients with compensated chronic HDV infection as indicated by presence of anti-HDV in serum.
Liver biopsy should be performed within one-year of study screening and graded using the Knodell scoring system.
Presence of HDV antigen in liver tissue or HDV-RNA in serum.
Active HBV replication will not exclude patients.
Previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
Patients who are HBV therapy-naïve or who previously received HBV antiviral therapy will be eligible. Patients currently taking HBV antiviral therapy will e considered on a case basis.
Female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of EBP921 dosing.
Exclusion Criteria:
Severe neuropsychiatric disorders
History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
Pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
Underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, HIV antibody positive, AIDS)
Chronic (> 4 weeks duration) diarrhea
Body weight > 128 kg and < 40 kg
Uncompensated cirrhosis
Absolute neutrophil count less than 1500 per cubic millimeter
Platelet count less than 90,000 per cubic millimeter
Evidence of concurrent HCV infection with positive serum HCVRNA
Evidence of hepatocellular carcinoma
Active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
Diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
Any experimental therapy in the previous 6 months prior to enrollment.
16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Murphy, MD, MPH
Organizational Affiliation
Eiger BioPharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
San Francisco
State/Province
California
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)
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